Clinical Data

Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile

Jeffrey D. Campbell , Bruce J. Trock, Adam R. Oppenheim, Ifeanyichukwu Anusionwu, Ronak A. Gor and Arthur L. Burnett

Abstract

Background: The aim of this study was to perform a meta-analysis of randomized controlledtrials (RCTs) that evaluate the efficacy of low-intensity extracorporeal shock wave therapy(LiESWT) for the treatment of erectile dysfunction (ED).

Materials and methods: A comprehensive search of PubMed, Medline, and Cochranedatabases was performed from November 2005 to July 2018. RCTs evaluating efficacyof LiESWT in the treatment of ED were selected. The primary outcomes were the meandifference between treatment and sham patients in the International Index of ErectileFunction-Erectile Function (IIEF-EF) domain score 1 month after treatment, and themean change in IIEF-EF from baseline to 1 month post-treatment. The secondary analysisconsidered the percentage of men whose erectile hardness score (EHS) changed from<2 at baseline to >3 after treatment. All analyses used a random effects method to poolstudy-specific results.

Results: A total of seven RCTs provided data for 607 patients. The mean IIEF-EF 1 monthpost-treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17–16.43 in thesham group. The mean difference between the treatment and sham groups at the 1 monthfollow up was a statistically significant increase in IIEF-EF of 4.23 (p = 0.012). Overall,five of the seven trials provided data on the proportion of patients with baseline EHS <2who improved to EHS >3 at 1 month post-treatment. The proportions ranged from 3.5 to90% in the treatment group versus 0–9% in the sham group and the pooled relative risk ofEHS improvement for the treated versus sham group was 6.63 (p = 0.0095). No significantadverse events were reported.

Conclusions: This is the first meta-analysis that evaluates RCTs exploring LiESWT as atreatment modality strictly for ED. This therapeutic strategy appears to be well tolerated withshort-term benefits. However further studies exploring specific treatment regimens and longtermoutcomes are needed

Effects of low-intensity shock wave therapy (LiST) on the erectile tissue of naturally aged rats.

Sokolakis I, Dimitriadis F, Psalla D, Karakiulakis G, Kalyvianakis D, Hatzichristou D.

Abstract

Background: Low-intensity shock wave therapy (LiST) improves erectile function in patients with erectile dysfunction (ED), probably by promoting angiogenesis as suggested by studies on animals with comorbidities as disease associated ED models.

Aim: To investigate the effects of LiST on erectile tissue of healthy, naturally aged rats.

Methods: Twelve aged male Wistar albino rats (19-21 months) were randomized into two groups: a control group (OC, n=6) and a LiST treatment group (OSWT, n=6).

Another young control group (8 weeks) (n=6) was also used (YC). Each rat in OSWT group received 300 shockwaves with an energy flux density of 0.09mJ/mm2 at 2 Hz.

Sessions were repeated three times/week for two weeks, followed by a two week washout period. Penile tissues were harvested and analysed with real time reverse transcription polymerase chain reaction (qRT-PCR) and immunohistochemical analysis (IHC).

Main Outcome Measures: Expressions of vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS), nerve growth factor (NGF) and neuronal NOS (nNOS), as well as a1 and a2-adrenergic receptors (a1AR, a2AR).

Further IHC for the significant mRNA expressions was performed.

Results: The expression of VEGF, eNOS and a2AR/a1AR ratio were increased (ANOVA: p=0.039, p=0.048 and p=0.008 respectively). The expression of NGF was not affected, but an increase in nNOS was observed (p=0.093). The increase of VEGF, eNOS as well as a2AR was also observed in IHC.

Clinical Translation: LiST showed to reverse pathology associated with aging in the erectile tissue in rats, which supports future research for ED prevention.

Conclusion: VEGF and eNOS expressions seem to play key role in the mechanism of action of LiST, apparently by inducing angiogenesis. For the first time a positive modulation of sympathetic nerve system as expressed by increased a2AR/a1AR ratio was also observed.

Key words

shockwave therapy, erectile tissue, erectile dysfunction, ESWT, LiST, aged rat

 

Low Intensity Shock Wave Treatment for Erectile Dysfunctiond - How Long Does the Effect Last?

Noam D. Kitrey,* Yoram Vardi, Boaz Appel,† Arik Shechter, Omar Massarwi, Yasmin Abu-Ghanem and Ilan Gruenwald

Abstract

Purpose: We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome.
Materials and Methods: Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) question-naire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference.
Results: We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years.
Conclusions: Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved.

Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients with Vasculagenic ED: A Triplex Ultrasonography-Based Sham-Controlled Trail

Dimitrios Kalyvianakis, MD, FECSM, Dimitrios Hatzichristou, MD, PhD, FECSM Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki Greece, Thessaloniki, Greece

Abstract

Background: Although several reports have documented the subjective improvement of erectile function after low-intensity extracorporeal shockwave therapy (LI-ESWT) in patients with vasculogenic erectile dysfunction (ED), objective assessment data of penile hemodynamics are lacking.

Aim: To assess penile hemodynamics before and 3 months after LI-ESWT in a group of patients with documented vasculogenic ED.

Methods: This was a double-blinded, randomized, sham-controlled trial. Forty-six patients with ED were randomized; 30 underwent LI-ESWT and 16 had a sham procedure in double-blinded fashion. All patients underwent penile triplex ultrasonography by the same investigator immediately before and 3 months after treatment. Patient demographics, International Index of Erectile Function erectile function domain (IIEF-ED) score, and minimal clinically important difference were assessed at baseline and 1, 3, 6, 9, and 12 months after treatment.

Outcomes: Changes in peak systolic velocity and resistance index as measured by triplex ultrasonography at baseline and 3 months after treatment were the main outcomes of the study. Secondary outcomes were changes in the IIEF-EF score from baseline to 1, 3, 6, 9, and 12 months after treatment and the percentage of patients reaching a minimal clinically important difference during the same period for the two groups.

Results: IIEF-EF minimal clinically important differences for the active vs sham group were observed for 56.7% vs 12.5% (P = .005) at 1 month, 56.7% vs 12.5% (P = .003) at 3 months, 63.3% vs 18.8% (P = .006) at 6 months, 66.7% vs 31.3% (P = .022) at 9 months, and 75% vs 25% (P = .008) at 12 months. Mean peak systolic velocity increased by 4.5 and 0.6 cm/s in the LI-ESWT and sham groups, respectively (P < .001).

Clinical Implications: Such results offer objective and subjective documentation of the value of this novel treatment modality for men with vasculogenic ED.

Strengths and Limitations: Strengths include the prospective, randomized, sham-controlled type of study and the assessment of penile hemodynamics. Limitations include the small sample and strict inclusion criteria that do not reflect everyday clinical practice.

Conclusion: The present study confirms the beneficial effect of LI-ESWT on penile hemodynamics and the beneficial effect of this treatment up to 12 months.

Low Intensity Extracorporeal Shockwave Therapy (Li-ESWT) Improves Erectile Function in a Model of Type II Diabetes Independently of NO/cGMP Pathway

Rana Assaly-Kaddoum, Francois Giuliano, Miguel Laurin, Diane Gomy, Micheline Kergoat, Jacques Bernabe, Yoram Vardi, Laurent Alexandre, Delphine Behr-Roussel

Purpose:

Erectile Dysfunction (ED) is highly prevalent in type II diabetes mellitus (T2DM). Li-ESWT improves erectile function in patients with ED from vasculogenic origin including diabetes, although its mode of action remains unknown.

Penile low-intensity shockwave treatment is able to shift PDE5i non-responders to responders: A double-blind sham-controlled study

Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y,

Purpose:
Sham-controlled evaluation of penile low-intensity shockwave treatment (LIST) effect on patients unable to have sexual intercourse with phosphodiesterase 5 inhibitors.

Impact of aging and comorbidity on the efficacy of low-intensity shock wave therapy for erectile dysfunction

Hisasue SI, China T, Horiuchi A, Kimura M, Saito K, Isotani S, Ide H, Muto S2, Yamaguchi R2, Horie S.

Objectives:  

To evaluate the efficacy of low-intensity shock wave therapy and to identify the predictive factors of its efficacy in Japanese patients with erectile dysfunction.

 

The Safety and Efficacy of Li-ESWT in 604 patients for Erectile Dysfunction: Summary of Current and Evolving Evidence

Robert A. Feldman, Bela S. Denes, Boaz Appel, Satya S. Vasan, Tamar Shultz and Arthur L. Burnett

Low intensity shock wave therapy (Li-ESWT) is currently approved in over 20 countries and available at over 200 clinics worldwide. A US multicenter study has been completed and the data are currently under FDA review. Herein we provide an overview of the clinical experience to date on the safety and efficacy of Li-ESWT for the treatment of erectile dysfunction. Studies were conducted in men with ED considered responders and in men considered poor responders to PDE5i. We report pooled data from 5 randomized, placebo-controlled studies (USA, Israel, Greece and India) and 3 single-arm open label studies (Israel, Japan). Li-ESWT for ED has been recently included in the European Association of Urology guideline 2013 for male sexual dysfunction.

New Therapeutics for ED - Prof. Peter Lim, Singapore

UroFair 2015

Prof. Peter Lim, Singapore, in a lecture in which he presented his latest results using ED1000, during UroFair 2015.

Low Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: a Study in an Indian Population

Srini Satya Vasan, Reddy Kumar Rahul, Shultz Tamar, Denes Bela

Erectile dysfunction (ED) has been shown to be associated with a number of physical conditions and affects not only physical but also psychosocial health. Currently oral, on-demand phosphodiesterase type 5 inhibitors (PDE5i) are preferred first line treatment. Though effective, these drugs have limitations and are associated with significant non-compliance, side effects and do not reverse the underlying pathology. Non-invasive low intensity shockwave therapy (LISWT) has been shown to significantly improve erectile function in men previously PDE5i dependent. The study describe the experience and results with this therapy in an Indian population of men with ED. It assessed the efficacy of low intensity extracorporeal shockwave therapy (LI-ESWT) on Indian men with organic ED who had previously responded to PDE5i.

EDSWT is the gold standard for the Treatment of ED

Low Intensity Shock Wave Therapy (EDSWT) was officially accepted by the European Association of Urology (EAU) as the gold standard for treatments of Erectile Dysfunction in the EAU 2013 guidelines on Male Sexual Dysfunction. This was based on clinical trials using the Medispec’s ED1000.

Penile Low-Intensity Shock Wave Therapy: A Promising Novel Modality for Erectile Dysfunction

Yasmin Abu-Ghanem,* Noam D. Kitrey,* Ilan Gruenwald, Boaz Appel, and Yoram Vardi

Penile extracorporeal low-intensity shock wave therapy (LIST) to the penis has recently emerged as a novel and promising modality in the treatment of erectile dysfunction (ED). LIST has angiogenic properties and stimulates neovascularization..

The Low-Intensity Shock Wave Therapy for Erectile Dysfunction

Shin-ichi Hisasue, M.D. Ph.D.

I'Phosphodiesterase type 5 inhibitors (PDE5i) revolutionized the treatment of erectile dysfunction (ED). However, even in vasculogenic ED patients, one fifth of them showed poor response to PDE5i. Low-intensity shock wave therapy (LI-ESWT) is a novel and promising modality for the patients with mild to moderate erectile dysfunction (ED).

Shockwave Treatment of Erectile Dysfunction

Ilan Gruenwald, Boaz Appel, Noam D. Kitrey and Yoram Vardi

Low-intensity extracorporeal shock wave therapy (LI-ESWT) is a novel modality that has recently been developed for treating erectile dysfunction (ED). Unlike other current treatment options for ED, all of which are palliative in nature, LI-ESWT is unique in that it aims to restore the erectile mechanism in order to enable natural or spontaneous erections.

Does Low Intensity Extracorporeal Shock Wave Therapy Have a Physiological Effect on Erectile Function? Short-Term Results of a Randomized, Double-Blind, Sham Controlled Study

Yoram Vardi, Boaz Appel, Amichai Kilchevsky, Ilan Gruenwald

Purpose:

We investigated the clinical and physiological effect of low intensity extracorporeal shock wave therapy on men with organic erectile dysfunction who are phosphodiesterase type 5 inhibitor responders.

 

 

 

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